MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-03-11 for S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT manufactured by Ge Healthcare Finland Oy.
[4288491]
The customer reports the neuro-muscular transmission module (nmt) provided inaccurate values during a case. Allegations from the facility were that they had some patients who were only partially paralyzed as part of the anesthesia process because of the faulty nmt result, and had to be re-intubated in the post anesthesia care unit. Details on these additional cases were not available from the facility.
Patient Sequence No: 1, Text Type: D, B5
[11665703]
Patient data not available. The reported issue is that the tof% should decrease slowly during the time the neuro-muscular block increases. In addition, a count of "0" means that the patient is fully relaxed due to the administered relaxants; however the fact that the anesthetist can visually see that the hand is moving indicates that the patient is not fully relaxed. Investigation reveals the root cause was found to be e-nmt-01 insufficient system test coverage. The e-nmt-01 module software and hardware differs from the previous version design.
Patient Sequence No: 1, Text Type: N, H10
[23933584]
(b)(4). Will correct the e-nmt-01 modules in the field to be capable of measuring with electrosensor accurately.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2014-00003 |
| MDR Report Key | 3687409 |
| Report Source | 01,05,06 |
| Date Received | 2014-03-11 |
| Date of Report | 2013-09-04 |
| Date of Event | 2013-09-04 |
| Date Mfgr Received | 2014-03-04 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEB LAHR |
| Manufacturer Street | 540 W. NORTHWEST HWY W450 |
| Manufacturer City | BARRINGTON IL 60010 |
| Manufacturer Country | US |
| Manufacturer Postal | 60010 |
| Manufacturer Phone | 8472774472 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| Manufacturer Street | KUORTANEENKATU 2 |
| Manufacturer City | HELSINKI, 510 |
| Manufacturer Country | FI |
| Manufacturer Postal Code | 510 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 9610105-02/24/14-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT |
| Generic Name | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC |
| Product Code | KOI |
| Date Received | 2014-03-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-11 |